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Kenneth A Perkins, FDA Policy on Setting Maximum Nicotine Content in Cigarettes, Nicotine & Tobacco Research, Volume 21, Issue 7, July 2019, Pages 996–997, https://doi.org/10.1093/ntr/nty068
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The Food and Drug Administration (FDA) recently posted an advance notice of proposed rulemaking (ANPRM) to set a maximum nicotine content in cigarettes to minimize their addictiveness.1 This policy would aim to help dependent smokers be more successful in attempts to quit smoking, as well as minimize risks of becoming dependent among youth who initiate tobacco smoking.2 Recent research has estimated the potential public health benefits of such a policy but did not provide data to establish what that level should be.3 In the major issues raised, the ANPRM states that “FDA is particularly interested in comments about the merits of nicotine levels like 0.3, 0.4, and 0.5 mg nicotine/g of tobacco filler, as well as other levels of nicotine.” Similarly, the World Health Organization (WHO) notes the threshold for addiction is likely to be at or below a cigarette nicotine content of 0.4 mg/g.4
A wide array of research is likely necessary to document a nonaddictive level of nicotine in smoked tobacco.5 Among the four study “types” of interest to FDA in addressing such a nicotine standard are “indirect estimates of an addiction threshold.” Although few data are available, our recent research provides indirect support on the potential for nonaddictive nicotine levels at or below 0.5 mg/g. We recently conducted studies with Spectrum research cigarettes obtained from NIDA that allow different fixed amounts of moderate and very low filler nicotine contents (ranging from 0.4 to 13 mg/g), to assist FDA by indirectly estimating an addiction threshold. After developing and evaluating a procedure for assessing ability to discriminate nicotine via tobacco cigarettes,6 our research assessed the threshold for ability to discriminate moderate to low nicotine cigarettes from the lowest available nicotine cigarette content, or 0.4 mg/g (“ultra-low”). Discrimination testing involved comparing this lowest content cigarette, 0.4 mg/g, with each of the higher nicotine content cigarettes, followed by a “choice” test as to which cigarette they preferred to smoke (ie, self-administered). Note the 0.4 mg/g was the lowest available because a policy to decrease content to zero, that is “placebo” cigarette, is currently prohibited by law.1 Such formal drug discrimination research, used in preclinical and clinical studies, objectively tests whether individuals can reliably perceive differences between psychoactive drug doses based solely on the resulting acute interoceptive stimulus effects.7 This assessment is potentially very relevant to helping identify a threshold dose for addiction, as it is unlikely that a very low dose that cannot be discriminated by smokers will support the onset or persistence of dependence2,5; smoked products virtually free of nicotine (eg, herbal) are not known to be reinforcing or cause dependence.
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